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Completed

NCT Number: NCT02720276

Sms Guided Training After Acute Stroke

The purpose of this exploratory study is to investigate how a predetermined outdoor walking program (12 weeks) is best delivered to individuals with stroke over 18 years, either by smartphone and the Short Message Service (SMS) or video link.

Furthermore, the aim is to investigate how the study design works in practice and determine the effects of the outdoor walking exercise program in combination with a leg exercise on physical functioning (walking capacity, gait speed, mobility and grip strength).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Twenty community-living individuals in Uppsala municipality will be included and treated with a cross-over design. Ten individuals will initially receive exercise instructions to their smartphones via Short Message Service (SMS) for 6 weeks and after that instructions by a video link (6 weeks). Another 10 individuals will initially receive instructions by a video link and then switching to management with SMS after 6 weeks of training.

Intervention: Participants are supposed to perform an outdoor walking exercise program for 12 weeks. The walks should gradually increase in frequency and intensity, and is expected to start after discharge from the stroke department, after the assessment. The first 2 weeks start with daily walks. The walks will be conducted at a pace that increases the heart rate but still makes it possible to talk. The intensity and frequency of walks will progressively increase performed according to the Borg scale: 12-15, ie, moderate to strenuous. Participants will walk 5-7 days/week. Added to this is a strength exercise, which should be performed in connection with the walk training.

Methods: Questionnaires and medical records used for documentation of age, sex, comorbidity, blood pressure, medications and previous education.

Assessment of motor function, cognition, level of physical activity are only performed as screening at baseline measurements. Objective evaluation of the participants' adherence to the outdoor walking program will be measured with a training diary where the individual documents whether they have followed the training instructions.

Power analysis is not performed since this is an exploratory study. The investigators will analyze the data using an intention-to -treat. The investigators will also do a 'per-protocol analysis, where only participants who completed the training are included. Participants should have participated in at least 50% of the training sessions. All analyzes will be done using SPSS version 23 (IBM, Armonk).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years
  • Verified ischemic cerebral infarction or intracerebral hemorrhage.
  • Sufficient walking capacity and motor function
  • Able to communicate in Swedish
  • Signed consent

Exclusion criteria

Are one or more of the following:

  • Subarachnoid bleeding
  • Insufficient cognition and impaired ability to understand instructions
  • Medical problems that make it unsuitable to participate

Treatment and study plan

Training after acute stroke

Other

Outdoor walking: Participants will receive daily training instructions via Short message Service (SMS) over 12 weeks. The walks are increased in frequency and intensity. The intensity are rated using the Borg scale to 12-15. The first 2 weeks begins with daily walks of 10 minutes. The last 4 weeks the walk training will partly be performed in intervals in combination with conventional outdoor walks. The interval training includes warming-up (5 minutes), fast walking for 4 minutes alternated with slower walking for three minutes. This is repeated 3 times, followed by cooling down for about five minutes. Strength training: to repeatedly get up from sitting. Number of repetitions will increase from 5-20 per set and will be performed daily in 3 sets with a short rest between each set.

Primary outcomes

  1. 6 Minutes Walk Test

    Time frame: change from baseline walking capacity to three months

    walking capacity

Secondary outcomes

  1. Short Physical Performance Battery

    Time frame: change from baseline mobility to three months

    mobility

  2. 10 meters walk test

    Time frame: change from baseline gait speed to three months

    gait speed

  3. Montreal Outcome Assessment

    Time frame: baseline

    cognitive function

  4. Modified Rankin Scale

    Time frame: baseline

    motor function

  5. Saltin Grimby Physical Activity Level Scale

    Time frame: baseline

    level of physical activity

  6. Jamar hand dynamometer

    Time frame: change from baseline hand-grip strength to three months

    hand-grip strength

  7. The Visual Analogue Rating Scale (VAS)

    Time frame: change from six baseline to three months.

    Report of how to deliver the best instructions.

  8. The Visual Analogue Rating Scale (VAS)

    Time frame: change from baseline to three months.

    Report of how to deliver the best instructions.

Sponsors and collaborators

Lead sponsor

Uppsala County Council, Sweden

Other Gov

Registry information

Official study title

Sms Guided Training After Acute Stroke: A Pilot Study

Acronym: StrokeWalk

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 25, 2016
Registry last updated
Sep 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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